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Lenalidomide - Generic Drug Details

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What are the generic drug sources, and freedom to operate, for lenalidomide?

Lenalidomide is the generic ingredient in one branded drug marketed by Celgene and is included in one NDA. There are twenty-seven patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

This ingredient has four hundred and forty-three patent family members in forty-five countries.

There are nine drug master file entries for lenalidomide. One supplier is listed for this compound.

Summary for Generic Name: lenalidomide

Tradenames:1
Patents:28
Applicants:1
NDAs:1
Drug Master File Entries: see list9
Suppliers / Packagers: see list1
Bulk Api Vendors: see list87
Clinical Trials: see list465
Patent Applications: see list329
Therapeutic Class:Antineoplastics
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:lenalidomide at DailyMed

Pharmacology for Ingredient: lenalidomide

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Celgene
REVLIMID
lenalidomide
CAPSULE;ORAL021880-001Dec 27, 2005RXYesNo8,315,886► Subscribe ► Subscribe
Celgene
REVLIMID
lenalidomide
CAPSULE;ORAL021880-006Jun 5, 2013RXYesNo7,465,800► SubscribeYY ► Subscribe
Celgene
REVLIMID
lenalidomide
CAPSULE;ORAL021880-003Jun 29, 2006RXYesNo6,755,784► Subscribe ► Subscribe
Celgene
REVLIMID
lenalidomide
CAPSULE;ORAL021880-001Dec 27, 2005RXYesNo8,288,415► SubscribeYY ► Subscribe
Celgene
REVLIMID
lenalidomide
CAPSULE;ORAL021880-004Jun 29, 2006RXYesYes► Subscribe► Subscribe
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Expired Orange Book Patents for Generic Ingredient: lenalidomide

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Celgene
REVLIMID
lenalidomide
CAPSULE;ORAL021880-002Dec 27, 20056,281,230► Subscribe
Celgene
REVLIMID
lenalidomide
CAPSULE;ORAL021880-003Jun 29, 20066,555,554► Subscribe
Celgene
REVLIMID
lenalidomide
CAPSULE;ORAL021880-001Dec 27, 20056,281,230► Subscribe
Celgene
REVLIMID
lenalidomide
CAPSULE;ORAL021880-001Dec 27, 20057,119,106► Subscribe
Celgene
REVLIMID
lenalidomide
CAPSULE;ORAL021880-001Dec 27, 20056,555,554► Subscribe
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Non-Orange Book Patents for Generic Ingredient: lenalidomide

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
7,141,018Methods for delivering a drug to a patient while restricting access to the drug by patients for whom the drug may be contraindicated► Subscribe
5,798,368 Tetrasubstituted 2-(2,6-dioxopiperidin-3-yl)-1-oxoisoindolines and method of reducing TNF.alpha. levels► Subscribe
8,623,384Methods using 3-(4-amino-1-oxo-1,3-dihydro-isoindol-2-yl)-piperidine-2,6-dione for treatment of acute myelogenous leukemia► Subscribe
7,959,566Methods for delivering a drug to a patient while restricting access to the drug by patients for whom the drug may be contraindicated► Subscribe
6,869,399 Methods for delivering a drug to a patient while restricting access to the drug by patients for whom the drug may be contraindicated► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Ingredient: lenalidomide

Country Document Number Estimated Expiration
South Africa200503025► Subscribe
China102675281► Subscribe
Portugal2426118► Subscribe
China104059052► Subscribe
TaiwanI430797► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: LENALIDOMIDE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
00717Netherlands► SubscribePRODUCT NAME: POMALIDOMIDE EN FARMACEUTISCH AANVAARDBARE ZOUTEN, SOLVATEN, HYDRATEN OF STEREOISOMEREN DAARVAN; REGISTRATION NO/DATE: EU/1/13/850 20130805
359Luxembourg► Subscribe91359, EXPIRES: 20220614
2015 00006Denmark► SubscribePRODUCT NAME: POMALIDOMID OG FARMACEUTISK ACCEPTABLE SALTE, SOLVATER, HYDRATER ELLER STEREOISOMERER HERAF; REG. NO/DATE: EU/1/13/850 20130805
642Luxembourg► SubscribePRODUCT NAME: POMALIDOMIDE ET SES SELS, SOLVATES, HYDRATES OU STEREOISOMERES PHARMACEUTIQUEMENT ACCEPTABLES QUI EN DERIVENT (IMNOVID); FIRST REGISTRATION DATE: 20130805
C033/2007Ireland► SubscribeSPC033/2007: 20080507, EXPIRES: 20220613
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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